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ACTEMRA- tocilizumab injection, solution, concentrateACTEMRA- tocilizumab injection, solutionACTEMRA ACTPEN- tocilizumab injection, solution


  1. Patient Information
  2. Think You Have An Infection Or Have Symptoms Of An Infection, With Or Without A Fever, Such As:
  3. Liver Problems (hepatotoxicity):
  4. Actemra Is A Prescription Medicine Called An Interleukin-6 (il-6) Receptor Antagonist. Actemra Is Used To Treat:
  5. Do Not Take Actemra:
  6. Into A Vein (iv Or Intravenous Infusion) For Rheumatoid Arthritis, Pjia, Sjia, Or Crs:
  7. Actemra Can Cause Serious Side Effects, Including:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Patient Counseling

Advise patients and parents or guardians of minors with PJIA, SJIA, or CRS of the potential benefits and risks of ACTEMRA.

  • Infections
    Inform patients that ACTEMRA may lower their resistance to infections. Instruct the patient of the importance of contacting their doctor immediately when symptoms suggesting infection appear in order to assure rapid evaluation and appropriate treatment.
  • Gastrointestinal Perforation
    Inform patients that some patients who have been treated with ACTEMRA have had serious side effects in the stomach and intestines. Instruct the patient of the importance of contacting their doctor immediately when symptoms of severe, persistent abdominal pain appear to assure rapid evaluation and appropriate treatment.
  • Hypersensitivity and Serious Allergic Reactions
    Assess patient suitability for home use for subcutaneous injection. Inform patients that some patients who have been treated with ACTEMRA have developed serious allergic reactions, including anaphylaxis. Advise patients to

    ACTEMRA can cause serious side effects including:

    1.
    Serious Infections. ACTEMRA is a medicine that affects your immune system. ACTEMRA can lower the ability of your immune system to fight infections. Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting ACTEMRA.

    Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment with ACTEMRA.

    • You should not start taking ACTEMRA if you have any kind of infection unless your healthcare provider says it is okay.

Think You Have An Infection Or Have Symptoms Of An Infection, With Or Without A Fever, Such As: 

  • sweating or chills
  • shortness of breath
  • warm, red, or painful skin or sores on your body
  • feel very tired
  • muscle aches
  • blood in phlegm
  • diarrhea or stomach pain
  • cough
  • weight loss
  • burning when you urinate or urinating more often than normal
  • are being treated for an infection.
  • get a lot of infections or have infections that keep coming back.
  • have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
  • have TB, or have been in close contact with someone with TB.
  • live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidiomycosis, or blastomycosis). These infections may happen or become more severe if you use ACTEMRA. Ask your healthcare provider, if you do not know if you have lived in an area where these infections are common.
  • have or have had hepatitis B.

After starting ACTEMRA, call your healthcare provider right away if you have any symptoms of an infection. ACTEMRA can make you more likely to get infections or make worse any infection that you have.

2.
Tears (perforation) of the stomach or intestines.
  • Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking ACTEMRA get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
  • Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away, and a change in your bowel habits.
3.

Liver Problems (hepatotoxicity): 

Some people have experienced serious life-threatening liver problems, which required a liver transplant or led to death. Your healthcare provider may tell you to stop taking ACTEMRA if you develop new or worse liver problems during treatment with ACTEMRA. Tell your healthcare provider right away if you have any of the following symptoms:
  • feeling tired (fatigue)
  • lack of appetite for several days or longer (anorexia)
  • yellowing of your skin or the whites of your eyes (jaundice)
  • abdominal swelling and pain on the right side of your stomach-area
  • light colored stools
  • weakness
  • nausea and vomiting
  • confusion
  • dark "tea-colored" urine
4.
Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start receiving ACTEMRA. If you have rheumatoid arthritis (RA) or giant cell arteritis (GCA) your healthcare provider should do blood tests every 4 to 8 weeks after you start receiving ACTEMRA for the first 6 months and then every 3 months after that. If you have polyarticular juvenile idiopathic arthritis (PJIA) you will have blood tests done every 4 to 8 weeks during treatment. If you have systemic juvenile idiopathic arthritis (SJIA) you will have blood tests done every 2 to 4 weeks during treatment. These blood tests are to check for the following side effects of ACTEMRA:
  • low neutrophil count. Neutrophils are white blood cells that help the body fight off bacterial infections.
  • low platelet count. Platelets are blood cells that help with blood clotting and stop bleeding.
  • increase in certain liver function tests.
  • increase in blood cholesterol levels. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start receiving ACTEMRA.
Your healthcare provider will determine how often you will have follow-up blood tests. Make sure you get all your follow-up blood tests done as ordered by your healthcare provider.
You should not receive ACTEMRA if your neutrophil or platelet counts are too low or your liver function tests are too high.
Your healthcare provider may stop your ACTEMRA treatment for a period of time or change your dose of medicine if needed because of changes in these blood test results.
5.
Cancer.ACTEMRA may increase your risk of certain cancers by changing the way your immune system works. Tell your healthcare provider if you have ever had any type of cancer.

Actemra Is A Prescription Medicine Called An Interleukin-6 (il-6) Receptor Antagonist. Actemra Is Used To Treat: 

  • Adults with moderately to severely active rheumatoid arthritis (RA), after at least one other medicine called a Disease-Modifying Anti-Rheumatic Drug (DMARD) has been used and did not work well.
  • Adults with giant cell arteritis (GCA).
  • People with active PJIA ages 2 and above.
  • People with active SJIA ages 2 and above.
  • People age 2 years and above who experience severe or life-threatening Cytokine Release Syndrome (CRS) following chimeric antigen receptor (CAR) T cell treatment
  • ACTEMRA is not approved for subcutaneous use in people with CRS.

It is not known if ACTEMRA is safe and effective in children with PJIA, SJIA, or CRS under 2 years of age or in children with conditions other than PJIA, SJIA or CRS.

Do Not Take Actemra: 

if you are allergic to tocilizumab, or any of the ingredients in ACTEMRA.

Into A Vein (iv Or Intravenous Infusion) For Rheumatoid Arthritis, Pjia, Sjia, Or Crs: 

  • If your healthcare provider prescribes ACTEMRA as an IV infusion, you will receive ACTEMRA from a healthcare provider through a needle placed in a vein in your arm. The infusion will take about 1 hour to give you the full dose of medicine.
  • For rheumatoid arthritis or PJIA you will receive a dose of ACTEMRA about every 4 weeks.
  • For SJIA you will receive a dose of ACTEMRA about every 2 weeks.
  • For CRS you will receive a single dose of ACTEMRA, and if needed additional doses.
  • While taking ACTEMRA, you may continue to use other medicines that help treat your rheumatoid arthritis, PJIA, or SJIA such as methotrexate, non-steroidal anti-inflammatory drugs (NSAIDs) and prescription steroids, as instructed by your healthcare provider.
  • Keep all of your follow-up appointments and get your blood tests as ordered by your healthcare provider.

Actemra Can Cause Serious Side Effects, Including: 

  • Active ingredient: tocilizumab

    Inactive ingredients of Intravenous ACTEMRA: disodium phosphate dodecahydrate/sodium dihydrogen phosphate dihydrate buffered solution, polysorbate 80, sucrose, and Water for Injection.

    Inactive ingredients of Subcutaneous ACTEMRA: L-arginine hydrochloride, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, and Water for Injection.

    ACTEMRA is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
    Genentech, Inc.,A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990 US License No.1048
    2019 Genentech, Inc. All rights reserved.
    For more information, go to www.ACTEMRA.com or call 1-800-ACTEMRA.

    Instructions for Use
    ACTEMRA(AC-TEM-RA)
    (tocilizumab)
    Prefilled Syringe

    Read and follow the Instructions for Use that come with your ACTEMRA prefilled syringe before you start using it and each time you get a prescription refill. Before you use ACTEMRA prefilled syringe for the first time, make sure your healthcare provider shows you the right way to use it.

    • Do not remove the needle cap until you are ready to inject ACTEMRA.
    • Do not try to take apart the syringe at any time.
    • Do not reuse the same syringe.

    Parts of your ACTEMRA Prefilled Syringe(

    • Put your used needles and syringes including ACTEMRA in a FDA-cleared sharps disposal container right away after use(

      • Put your used ACTEMRA Autoinjector and green cap in a FDA-cleared sharps disposal container right away after use(SeeFigure M).
      • Do notthrow away (dispose of) the Autoinjector and the green cap in your household trash.Figure M
      • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
        • made of a heavy-duty plastic
        • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
        • upright stable during use
        • leak-resistant
        • properly labeled to warn of hazardous waste inside the container
          • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used Autoinjectors. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at:http://www.fda.gov/safesharpsdisposal.
          • Do notdispose of your used sharps disposal container in your household trash unless your community guidelines permit this.Do notrecycle your used sharps disposal container.

      Keep the ACTEMRA Autoinjector and disposal container out of the reach of children.

      Record your Injection

      • Write the date, time, and specific part of your body where you injected yourself. It may also be helpful to write any questions or concerns about the injection so you can ask your healthcare provider.

      If you have any questions or concerns about your ACTEMRA Autoinjector, talk to your healthcare provider familiar with ACTEMRA or call 1-800-ACTEMRA.

      This Medication Guide and Instructions for Use has been approved by the U.S. Food and Drug Administration.
      Medication Guide Revised: 06/2019
      ACTEMRA is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

      Genentech, Inc.
      A Member of the Roche Group
      1 DNA Way
      South San Francisco, CA 94080-4990

      US License No. 1048

      2019 Genentech, Inc. All rights reserved.

      Representative sample of labeling (see theHOW SUPPLIEDsection for complete listing):



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